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Pharma & Bio Ingredients
The clinical trial was intended to demonstrate that Lexapro was not inferior to Cymbalta, one of the researchers said. That it appeared to be more effective came as something of a surprise.
"Going in we thought Lexapro would do as well and be better tolerated," Dr. Arif Kahn, medical director of the Northwestern Clinical Research Center in Bellevue, Washington and one of the study's lead investigators, said in an interview.
"This was not expected. I didn't think it would reach statistical significance," said Kahn, who prescribes both medicines for depression in his practice.
The primary goal of the study was a 50 percent improvement in patients' depression symptoms as measured by a standard depression rating system known as MADRS (Montgomery and Aasberg Depression Rating Scale). Patients aged 18 to 80 began the study with a MADRS score of 26 or greater.
Sixty-eight percent of patients who received Lexapro reached the improvement goal compared to 52 percent who responded to treatment with Cymbalta. The result, which included patients who did not complete the full eight weeks of treatment, was deemed statistically significant, Kahn said.
In addition, 44 percent of the Lexapro patients experienced near total disappearance of depression symptoms compared with a 38-percent remission rate in the Cymbalta group, which was not statistically significant. Remission was defined as a score of 10 or less on the MADRS depression scale.
Lexapro belongs to a class of antidepressants called SSRIs, or selective serotonin reuptake inhibitors, that are among the most widely prescribed medicines for depression. Cymbalta belongs to a newer class called SNRIs that work on both serotonin and norepinephrine levels in the brain.
Lexapro, which Forest licenses from Denmark's H. Lundbeck A/S, had third-quarter sales of $522.7 million. Cymbalta's third-quarter sales were $348.6 million, but the newer drug is growing at a much faster pace.
The Forest drug had a significantly lower dropout rate in the study with 87 percent completing eight weeks of treatment compared with 69 percent of Cymbalta patients reaching the study's finish line.
Of those who discontinued treatment early, 13 percent of the Cymbalta group stopped due to adverse events, while just 2 percent of Lexapro patients who dropped out did so due to adverse events, such as nausea, dizziness, insomnia and decreased sexual drive.
"Lexapro is a very good antidepressant and this study further proves it," Kahn said.
